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SAFE Digital Signatures & FDA Electronic Submissions Gateway (ESG). Cindy Cullen SAFE CTO 609 818 4152. Agenda. SAFE credentialing process Electronic Submissions Gateway Regulatory Affairs Implementation Keys to Success. SAFE Credentialing Process. SAFE Signatures on FDA ESG. FDA.

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SAFE Digital Signatures & FDA Electronic Submissions Gateway (ESG)


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safe digital signatures fda electronic submissions gateway esg

SAFE Digital Signatures& FDA Electronic Submissions Gateway(ESG)

Cindy Cullen

SAFE CTO

609 818 4152

agenda
Agenda
  • SAFE credentialing process
  • Electronic Submissions Gateway
  • Regulatory Affairs
  • Implementation
  • Keys to Success
slide4

SAFE Signatures on FDA ESG

FDA

Issuer

AstraZeneca

1

2

ü

3

4

  • D1 Digital signature applied to the FDA form
  • V2 Validation of signature credential requested
  • V3 Validation report received
  • V4 Validation report and signature bound to document
  • D5 Digitally signed FDA form placed within compiled electronic submission. Submission moved to electronic archive
  • S6 Submissions sent to FDA via the FDA ESG
  • S7 Submission acknowledgments received
  • S8 Submission acknowledgment (receipt) placed into electronic archive with submission link page

ü

7

6

5

8

az regulatory affairs and safe
AZ Regulatory Affairs and SAFE
  • AZ Regulatory Affairs - why we got involved in implementing SAFE
    • In conjunction with the implementation of the FDA Electronic Submissions Gateway
      • AZRA involved in the pilot for the FDA ESG
  • Implementation FDA ESG
    • Requirement for digital signatures on FDA forms
      • Leverage experience and benefit from AZ membership on SAFE
      • Part 11 compliant
      • Future extension of benefit internally
      • Small group requiring credentials
az regulatory affairs and safe key concerns for the business
AZ Regulatory Affairs and SAFE Key Concerns for the Business
  • Compliance
  • Cost
  • Complexity
  • Training
  • Efficiency gained
  • Support
  • Timing
  • Reputation
first steps
First Steps
  • Formation of Project Team
  • Seek expertise
  • Determine user requirements
  • Investment/”buy-in” by key stakeholders
    • Legal
    • Records Management
    • Architecture
    • Infrastructure
    • Security
implementation
Implementation
  • Regulatory Affairs - determine and address process implications
    • “live” digital signature vs. flattened file
  • Software – off the shelf, Arcot addressed version SAFE 2.x ruleset
  • Validation - (eg, system requirements, user acceptance testing)
  • Infrastructure implications – Firewall (open required ports) and Proxy issue
    • Arcot software does not use proxy connection
    • AZ Internet Security Policy does not allow direct access on port 80
  • Deployment - Scripting for installation and rollout plan
    • Scripted for automatic rollout to users, complicated by reboot required after driver installation
      • Adobe Acrobat 7 Pro
      • SafeNet token drivers
      • SafeNet Middleware (policy)
      • Arcot Universal Client
implementation9
Implementation
  • Training
  • Credentialing - AZ's Trusted Agent – “pain-free registration”
  • Communications
  • Trouble shooting
    • Java version issues with RACCA registration application
    • Windows SmartCard services are activated by driver install – side effects
    • Apparent interaction with latest Citrix client
    • SafeNet installs four devices by default
    • Scripting difficulties in Arcot installation
    • Server based implementation for SAFE should reduce number of issues encountered
  • Security
    • Firewall policy
  • Support
keys to success
Keys to success
  • Leadership support
  • Use of experienced consultants
  • Communication,Communication,Communication
  • Training
  • Support
  • Lessons Learned
implementation architecture
Implementation Architecture
  • Electronic record represented using a PDF document.
  • the client-side document display application
  • SAFE-compliant Signing Interface, which generates and verifies the Digital Signature.
  • User SAFE Credential stored on a SafeNet Hardware Token and appropriate driver and middleware software
  • Regulatory compliant data repository
  • User credential certification authority which validates the digital signature – (via an OCSP request / response over the secure Internet connection)